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Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth.

NCT02124655 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-04-29

No results posted yet for this study

Summary

The accumulation and maturation of oral biofilm in the gingival margin is widely recognised to be the primary aetiological factor in the development of chronic gingivitis. Based on this association, the current treatment of gingivitis is focused on biofilm disruption, which will normally include mechanical processes, both professionally and at home. However, for patients, it is not easy to achieve a proper level of plaque control. The efficient plaque control techniques are very time consuming and require a special motivation and skills for their optimum use. It was at this point where mouthwashes become important, due to the fact that they include diverse types of antimicrobial agents to complement the results of mechanical oral hygiene measures.

Chlorhexidine is considered the "gold standard" of oral antiseptics; nevertheless it has not been recommended for long periods of time due to its well-known secondary effects. All of these inconveniences have limited its acceptability among dental professionals and users; in contrast, however, are the exceptional antiseptic properties, promoting the interest of researchers in other alternative antiplaque agents. Mouthwashes containing essential oils in their formulation have received a lot of attention. Their antiplaque activity has been demonstrated in numerous clinical studies, in which they were used in conjunction with mechanical oral hygiene measures.

In order to achieve a better understanding of the clinical effects that antimicrobial agents produce in the interior of the biofilm, it is necessary to apply a methodology in which the biofilm grows directly in the interior of the oral cavity but its three dimensional structure is not distorted by manipulation.

The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents (essential oils formulation and 0.2% chlorhexidine) in the short term with a posterior analysis on "non-destructured" biofilm with Confocal Laser Scanning Microscope combined with fluorescence staining.

Conditions

  • Oral Biofilm
  • Mouthwash
  • Periodontitis

Interventions

DRUG

Essential oils

DRUG

0.2% chlorhexidine

DRUG

Sterile water

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

  • University of Santiago de Compostela

    lead OTHER

Principal Investigators

  • Inmaculada Tomas · Senior lecturer at the University of Santiago de Compostela

Study Design

Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-06-30

Countries

  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02124655 on ClinicalTrials.gov